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Advancements in Transdermal Drug Delivery: Nanoemulgels, Essential Oils, and Innovations in Colchicine Delivery for Improved Anti-Inflammatory Effects and Permeability Enhancement. 经皮给药的进展:纳米凝胶、精油和秋水仙碱给药的创新,以改善抗炎作用和增强渗透性。
Pub Date : 2025-09-16 DOI: 10.2174/0126673878383010250911124710
Iram Jahan, Atul Pratap Singh, Gaurav

Introduction: Transdermal drug delivery (TDD) systems offer a patient-friendly alternative to oral and injectable routes by enhancing bioavailability and bypassing hepatic first-pass metabolism. Nanoemulgels, which integrate nanoemulsions with gel matrices, provide improved drug solubilization, stability, and skin permeation. Incorporating both herbal components, such as Nigella sativa oil, and synthetic permeation enhancers, presents a synergistic strategy for enhancing the efficacy of anti-inflammatory agents like colchicine.

Methods: This review critically evaluates the formulation, pharmacological benefits, and permeation- enhancing strategies of nanoemulgels containing colchicine. Literature was selected from major scientific databases, emphasizing studies that investigated the combined effects of herbal and synthetic excipients on drug delivery and therapeutic performance.

Results: Evidence indicates that nanoemulgels incorporating Nigella sativa oil and pharmaceuticalgrade permeation enhancers significantly improve colchicine's dermal absorption, sustain drug release, and reduce systemic toxicity. The synergistic interaction between natural bioactives and synthetic agents enhances both anti-inflammatory activity and skin permeability.

Discussion: The dual role of Nigella sativa as an anti-inflammatory and natural permeation enhancer, when paired with synthetic excipients, demonstrates superior pharmacodynamic outcomes. This integrated approach enhances the therapeutic index of colchicine while minimizing adverse effects.

Conclusion: Combining herbal oils like Nigella sativa with pharmaceutical excipients in nanoemulgel systems represents a robust strategy for transdermal delivery. This platform improves drug penetration, stabilizes formulation performance, and amplifies therapeutic efficacy, offering a transformative alternative for chronic inflammatory conditions such as gout.

简介:经皮给药(TDD)系统通过提高生物利用度和绕过肝脏第一过代谢,为口服和注射途径提供了一种对患者友好的替代方案。纳米乳剂将纳米乳剂与凝胶基质结合在一起,可以改善药物的增溶性、稳定性和皮肤渗透性。结合这两种草药成分,如黑草油和合成渗透增强剂,提出了一种协同策略,以提高抗炎剂如秋水仙碱的功效。方法:本文综述了秋水仙碱纳米凝胶的配方、药理作用和渗透增强策略。文献选择主要的科学数据库,重点研究草药和合成辅料对药物传递和治疗效果的联合作用。结果:有证据表明,含有黑草油和药用级渗透促进剂的纳米凝胶可显著改善秋水仙碱的皮肤吸收,维持药物释放,降低全身毒性。天然生物活性与合成制剂之间的协同作用增强了抗炎活性和皮肤渗透性。讨论:黑草作为抗炎和天然渗透促进剂的双重作用,当与合成赋形剂配对时,显示出优越的药效学结果。这种综合方法提高了秋水仙碱的治疗指标,同时最大限度地减少了不良反应。结论:在纳米凝胶系统中结合黑皮草等草药油和药用辅料是一种有效的透皮给药策略。该平台提高了药物渗透,稳定了配方性能,并扩大了治疗效果,为痛风等慢性炎症疾病提供了一种变革性的替代方案。
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引用次数: 0
Needle-Free Future: Revolutionizing Immunization with Vaccine Creams. 无针未来:用疫苗药膏革新免疫。
Pub Date : 2025-08-29 DOI: 10.2174/0126673878398533250825152040
Dinesh Kumar, Vrinda Gupta, Rajni Tanwar, Sonia Gupta

For centuries, injections have been the primary method for vaccination; however, these traditional approaches present challenges due to pain, fear, and difficulties in administration. Scientists from Stanford University have developed vaccine creams, representing a revolutionary approach to the field of vaccination. Genetically modified Staphylococcus epidermidis forms the basis of these cream products, which support skin-based, painless vaccination without invasive procedures, while playing an essential role in the immune response. Scientists using tetanus as a test subject have obtained positive data from animal studies demonstrating effective immune responses to vaccination, indicating potential future applications for treating diseases, such as influenza, COVID-19, and cancer. Vaccination creams outperform classic injections in several ways, as they eliminate needle-related concerns while reducing adverse reactions, streamlining mass vaccination programs, and making the delivery of immunizations simpler, especially for populations that lack regular access to healthcare. Several key barriers continue to hinder the development of vaccine creams, including regulatory hurdles, stability concerns, production scalability, and public acceptance. Research discusses how vaccine creams revolutionize immunization processes by improving treatment accessibility, affordability, and broader acceptance rates.

几个世纪以来,注射一直是接种疫苗的主要方法;然而,由于疼痛、恐惧和管理困难,这些传统方法存在挑战。斯坦福大学的科学家们开发出了疫苗霜,代表了疫苗接种领域的一种革命性方法。转基因表皮葡萄球菌构成了这些乳霜产品的基础,它支持基于皮肤的无痛疫苗接种,而无需侵入性程序,同时在免疫反应中发挥重要作用。科学家利用破伤风作为试验对象,从动物研究中获得了积极的数据,表明疫苗接种对免疫反应有效,这表明疫苗未来可能应用于治疗流感、COVID-19和癌症等疾病。疫苗接种膏在几个方面优于传统注射,因为它们消除了与针头有关的问题,同时减少了不良反应,简化了大规模疫苗接种计划,并使免疫接种更加简单,特别是对于无法定期获得医疗保健的人群。几个主要障碍继续阻碍疫苗药膏的发展,包括监管障碍、稳定性问题、生产可扩展性和公众接受程度。研究讨论了疫苗霜如何通过提高治疗可及性、可负担性和更广泛的接受率来彻底改变免疫过程。
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引用次数: 0
Polymeric Nanocarriers with pH-Dependent Release for Tumor-Specific Delivery. 具有ph依赖性释放的高分子纳米载体用于肿瘤特异性递送。
Pub Date : 2025-08-21 DOI: 10.2174/0126673878366151250815012551
Chintan Aundhia, Ghanshyam Parmar, Chitrali Talele, Piyushkumar Sadhu, Avinshkumar Seth

The acidic nature of tumor microenvironments presents a unique opportunity for the targeted delivery of therapeutics using pH-responsive polymeric nanocarriers. These smart nanocarriers are designed to release their payload specifically in response to the low pH found in tumor tissues, thereby enhancing drug accumulation at the tumor site while minimizing systemic side effects. This review provides a comprehensive overview of the design principles, fabrication methods, and applications of pH-responsive polymeric nanocarriers for targeted drug delivery in tumor microenvironments. Key topics include the mechanisms of pH-responsive drug release, engineering strategies for developing pH-sensitive polymers, and recent advancements in exploiting tumor acidity for improved therapeutic outcomes. Additionally, the review discusses the clinical potential and the challenges associated with the translation of these nanocarriers from bench to bedside.

肿瘤微环境的酸性性质为使用ph反应性聚合物纳米载体靶向递送治疗提供了独特的机会。这些智能纳米载体被设计为针对肿瘤组织中发现的低pH值特异性释放其有效载荷,从而增强肿瘤部位的药物积累,同时最大限度地减少全身副作用。本文综述了ph响应型高分子纳米载体的设计原理、制备方法及其在肿瘤微环境中靶向给药的应用。关键主题包括ph反应性药物释放机制,开发ph敏感聚合物的工程策略,以及利用肿瘤酸度改善治疗效果的最新进展。此外,该综述还讨论了这些纳米载体从实验室到床边的转化的临床潜力和挑战。
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引用次数: 0
Nanorobots: Trailblazing the Future of Pharmaceuticals Through Targeted Therapy and Disease Monitoring. 纳米机器人:通过靶向治疗和疾病监测开拓药物的未来。
Pub Date : 2025-08-18 DOI: 10.2174/0126673878372947250731061921
P Sree Ranjani, S Sangeetha, K K Suriya Prakaash, N Damodharan

Introduction: This review explores the design principles, sensor mechanisms, and propulsion systems of nanorobots, highlighting their applications in targeted drug delivery, disease monitoring, and broader biomedical fields. The objective is to provide a comprehensive overview of how nanorobots transform pharmaceutical delivery systems and precision therapy.

Methodology: A structured literature search was conducted using electronic databases, including PubMed, Scopus, and Web of Science. Keywords such as Nanorobots, Nanorobot propulsion, Biosensors, Magnetically driven nanorobots, Electric field-driven nanorobots, Biomedical applications, and Enzyme-driven nanorobots were used. Articles published between 2010 and 2024 were considered. Inclusion criteria involved peer-reviewed articles focusing on nanorobot design, propulsion systems, sensor mechanisms, and clinical applications. Non-English articles and non-peer-reviewed content were excluded.

Results: A total of 212 relevant studies were initially identified through a comprehensive search across PubMed, Scopus, Web of Science, and Google Scholar. After applying inclusion and exclusion criteria, 94 studies were selected for final analysis, focusing on the integration of sensors, propulsion systems, and energy sources in nanorobots.

Discussion: The review revealed that nanorobots utilize advanced sensor systems (nanocantilevers and biosensors) for molecular recognition and site-specific targeting. These sensors detect biochemical and mechanical changes, aiding precise navigation. Powered by external forces (magnetic, electric, light, ultrasound) or internal biochemical energy (enzymatic or chemical reactions), propulsion mechanisms enable controlled movement and drug delivery. Nanorobots constructed from silicon, polymers, and piezoelectric compounds exhibit functional adaptability. Their applications span targeted drug delivery, oncology, neurosurgery, vascular medicine, and environmental remediation.

Conclusion: Nanorobots represent a trailblazing pharmaceutical innovation, offering highly specific, efficient, and minimally invasive drug delivery and disease monitoring capabilities. Their combination of biosensing and propulsion mechanisms enhances targeted delivery and clinical efficacy. Continued development in nanorobotic systems holds the potential to revolutionize clinical treatments and improve patient outcomes across multiple therapeutic domains.

本文综述了纳米机器人的设计原理、传感器机制和推进系统,重点介绍了纳米机器人在靶向给药、疾病监测和更广泛的生物医学领域的应用。目的是提供纳米机器人如何改变药物输送系统和精确治疗的全面概述。方法:使用PubMed、Scopus和Web of Science等电子数据库进行结构化文献检索。关键词:纳米机器人,纳米机器人推进,生物传感器,磁驱动纳米机器人,电场驱动纳米机器人,生物医学应用,酶驱动纳米机器人。2010年至2024年间发表的文章被纳入考虑范围。纳入标准包括同行评议的文章,重点是纳米机器人设计、推进系统、传感器机制和临床应用。非英文文章和非同行评议的内容被排除在外。结果:通过PubMed、Scopus、Web of Science和b谷歌Scholar的综合检索,初步确定了212项相关研究。在应用纳入和排除标准后,最终选择了94项研究进行分析,重点是纳米机器人中传感器、推进系统和能源的集成。讨论:综述揭示了纳米机器人利用先进的传感器系统(纳米反杠杆和生物传感器)进行分子识别和位点特异性靶向。这些传感器检测生化和机械变化,帮助精确导航。由外力(磁力、电、光、超声)或内部生化能量(酶或化学反应)提供动力,推进机制可以控制运动和药物输送。由硅、聚合物和压电化合物构成的纳米机器人表现出功能适应性。它们的应用范围包括靶向给药、肿瘤学、神经外科、血管医学和环境修复。结论:纳米机器人具有高度特异性、高效、微创的给药和疾病监测能力,是一项开创性的制药创新。它们结合了生物传感和推进机制,提高了靶向给药和临床疗效。纳米机器人系统的持续发展有可能彻底改变临床治疗,并改善多个治疗领域的患者预后。
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引用次数: 0
Optimized Formulation of Sulfasalazine and Probiotic-Loaded Carrageenan Microparticles Using Design of Experiments for Effective Colitis Management. 用实验设计优化磺胺吡啶和负载益生菌的卡拉胶微粒的配方,用于有效的结肠炎治疗。
Pub Date : 2025-08-18 DOI: 10.2174/0126673878363141250731125303
Sarmili Sahoo, Akshita Arora, Simranjeet Kaur, Diksha, Rohit Bhatia, Shamsher Singh, Raj Kumar Narang, Rajveer Singh, Naresh Kumar Rangra, Amandeep Singh

Introduction: Ulcerative colitis (UC) is a chronic inflammatory bowel disease marked by mucosal inflammation and epithelial barrier dysfunction. Sulfasalazine, a standard antiinflammatory drug, and probiotics, known for gut microbiota modulation, have both shown efficacy in UC management. However, their combined delivery to the colon remains underexplored. This study aimed to develop a colon-targeted microparticulate formulation containing sulfasalazine and a probiotic strain to enhance anti-inflammatory action and therapeutic effectiveness against UC.

Methods: Microparticles were prepared using a Design of Experiments (DoE) approach, optimizing carrageenan and calcium chloride dihydrate concentrations and stirring speed. The probiotic was co-encapsulated to maintain viability during processing. In vitro evaluations included drug release studies and Caco-2 cell line assays for epithelial integrity, ROS generation, and NF-κB expression. In vivo efficacy was assessed using an acetic acid-induced colitis model, with evaluations based on inflammation severity, tissue damage and histopathology.

Results: Optimized microparticles ensured sustained sulfasalazine release and preserved probiotic viability. In vitro, the formulation improved epithelial barrier function, reduced ROS and proinflammatory cytokines, and suppressed NF-κB expression. In vivo, treated animals showed significant reduction in colitis severity, improved tissue integrity and better histopathological outcomes compared to controls.

Discussion: The combined sulfasalazine-probiotic microparticles effectively addressed both symptomatic relief and the inflammatory cascade in UC. Probiotics enhanced gut barrier protection, while sustained sulfasalazine release ensured localized therapeutic action. The synergy between drug and probiotic delivery offers a novel approach over conventional therapies.

Conclusion: This study presents a promising colon-targeted microparticulate system combining sulfasalazine and probiotics for effective UC management. The dual-action formulation offers enhanced anti-inflammatory efficacy, reduced tissue damage, and better disease control, supporting its potential in future clinical applications.

溃疡性结肠炎(UC)是一种以黏膜炎症和上皮屏障功能障碍为特征的慢性炎症性肠病。磺胺吡啶,一种标准的抗炎药物,和益生菌,众所周知的肠道菌群调节,都显示出UC管理的有效性。然而,它们联合输送到结肠的方法仍未得到充分探索。本研究旨在开发一种含有磺胺吡啶和益生菌菌株的结肠靶向微颗粒制剂,以增强对UC的抗炎作用和治疗效果。方法:采用实验设计法(DoE)制备微颗粒,优化卡拉胶和氯化钙的浓度和搅拌速度。益生菌被共封装以在加工过程中保持活力。体外评价包括药物释放研究和Caco-2细胞系检测上皮完整性、ROS生成和NF-κB表达。使用醋酸诱导的结肠炎模型,根据炎症严重程度、组织损伤和组织病理学来评估体内疗效。结果:优化后的微颗粒保证了磺胺嘧啶的持续释放,并保持了益生菌的活力。在体外,该制剂可改善上皮屏障功能,降低ROS和促炎细胞因子,抑制NF-κB表达。在体内,与对照组相比,治疗后的动物结肠炎严重程度显著降低,组织完整性改善,组织病理学结果更好。讨论:联合磺胺吡啶-益生菌微颗粒有效解决UC的症状缓解和炎症级联。益生菌增强了肠道屏障保护,而持续的柳氮磺胺吡啶释放确保了局部治疗作用。药物和益生菌之间的协同作用提供了一种比传统疗法更新颖的方法。结论:本研究提出了一种结合磺胺吡啶和益生菌的结肠靶向微颗粒系统,可有效治疗UC。双作用配方具有增强的抗炎功效,减少组织损伤,更好的疾病控制,支持其在未来临床应用的潜力。
{"title":"Optimized Formulation of Sulfasalazine and Probiotic-Loaded Carrageenan Microparticles Using Design of Experiments for Effective Colitis Management.","authors":"Sarmili Sahoo, Akshita Arora, Simranjeet Kaur, Diksha, Rohit Bhatia, Shamsher Singh, Raj Kumar Narang, Rajveer Singh, Naresh Kumar Rangra, Amandeep Singh","doi":"10.2174/0126673878363141250731125303","DOIUrl":"https://doi.org/10.2174/0126673878363141250731125303","url":null,"abstract":"<p><strong>Introduction: </strong>Ulcerative colitis (UC) is a chronic inflammatory bowel disease marked by mucosal inflammation and epithelial barrier dysfunction. Sulfasalazine, a standard antiinflammatory drug, and probiotics, known for gut microbiota modulation, have both shown efficacy in UC management. However, their combined delivery to the colon remains underexplored. This study aimed to develop a colon-targeted microparticulate formulation containing sulfasalazine and a probiotic strain to enhance anti-inflammatory action and therapeutic effectiveness against UC.</p><p><strong>Methods: </strong>Microparticles were prepared using a Design of Experiments (DoE) approach, optimizing carrageenan and calcium chloride dihydrate concentrations and stirring speed. The probiotic was co-encapsulated to maintain viability during processing. In vitro evaluations included drug release studies and Caco-2 cell line assays for epithelial integrity, ROS generation, and NF-κB expression. In vivo efficacy was assessed using an acetic acid-induced colitis model, with evaluations based on inflammation severity, tissue damage and histopathology.</p><p><strong>Results: </strong>Optimized microparticles ensured sustained sulfasalazine release and preserved probiotic viability. In vitro, the formulation improved epithelial barrier function, reduced ROS and proinflammatory cytokines, and suppressed NF-κB expression. In vivo, treated animals showed significant reduction in colitis severity, improved tissue integrity and better histopathological outcomes compared to controls.</p><p><strong>Discussion: </strong>The combined sulfasalazine-probiotic microparticles effectively addressed both symptomatic relief and the inflammatory cascade in UC. Probiotics enhanced gut barrier protection, while sustained sulfasalazine release ensured localized therapeutic action. The synergy between drug and probiotic delivery offers a novel approach over conventional therapies.</p><p><strong>Conclusion: </strong>This study presents a promising colon-targeted microparticulate system combining sulfasalazine and probiotics for effective UC management. The dual-action formulation offers enhanced anti-inflammatory efficacy, reduced tissue damage, and better disease control, supporting its potential in future clinical applications.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144984992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advancements in Enteric-coated Microspheres Formulation Development and Mangiferin Drug Delivery for the Treatment of Ulcerative Colitis. 治疗溃疡性结肠炎的肠溶微球配方开发及芒果苷给药研究进展。
Pub Date : 2025-08-01 DOI: 10.2174/0126673878362674250630062020
Swati Yadav, Ranjit K Harwansh, Rupa Mazumder

Introduction: Ulcerative colitis, an inflammatory disease of the colon, is prone to recurrence. Research into novel therapies for this condition is urgently required. The current investigation aims to ascertain the protective impact of microspheres loaded with mangiferin in acetic acidinduced ulcerative colitis (UC).

Methods: The formulation significantly reduced inflammatory alterations, ulcer activity scores, and oxidative stress. Colitis was induced by injecting 1 mL of a 4% acetic acid solution. In addition to a macroscopical and gross evaluation, colon samples were tested for catalase and glutathione (GSH) activity.

Results: Microspheres loaded with mangiferin reduced the severity of ulcerative colitis caused by acetic acid, as indicated by improvements in weight loss, macroscopic score, ulcer area, and histological score.

Discussion: The anti-inflammatory effects of the microspheres may explain their ability to alleviate symptoms of acetic acid-induced ulcerative colitis.

Conclusion: These findings suggest that enteric-coated microspheres loaded with mangiferin exhibit a protective effect against colon ulcers in rats and offer delayed-release properties compared to plain mangiferin.

简介:溃疡性结肠炎是一种易复发的结肠炎症性疾病。迫切需要研究针对这种情况的新疗法。本研究旨在确定载芒果苷微球对醋酸性溃疡性结肠炎(UC)的保护作用。方法:该制剂可显著降低炎症改变、溃疡活性评分和氧化应激。注射1 mL 4%醋酸溶液诱导结肠炎。除了宏观和大体评估外,还测试了结肠样品的过氧化氢酶和谷胱甘肽(GSH)活性。结果:负载芒果苷的微球减轻了醋酸引起的溃疡性结肠炎的严重程度,体重减轻、宏观评分、溃疡面积和组织学评分均有改善。讨论:微球的抗炎作用可以解释它们减轻醋酸诱导的溃疡性结肠炎症状的能力。结论:这些研究结果表明,与普通芒果苷相比,负载芒果苷的肠溶微球对大鼠结肠溃疡具有保护作用,并具有延迟释放特性。
{"title":"Advancements in Enteric-coated Microspheres Formulation Development and Mangiferin Drug Delivery for the Treatment of Ulcerative Colitis.","authors":"Swati Yadav, Ranjit K Harwansh, Rupa Mazumder","doi":"10.2174/0126673878362674250630062020","DOIUrl":"https://doi.org/10.2174/0126673878362674250630062020","url":null,"abstract":"<p><strong>Introduction: </strong>Ulcerative colitis, an inflammatory disease of the colon, is prone to recurrence. Research into novel therapies for this condition is urgently required. The current investigation aims to ascertain the protective impact of microspheres loaded with mangiferin in acetic acidinduced ulcerative colitis (UC).</p><p><strong>Methods: </strong>The formulation significantly reduced inflammatory alterations, ulcer activity scores, and oxidative stress. Colitis was induced by injecting 1 mL of a 4% acetic acid solution. In addition to a macroscopical and gross evaluation, colon samples were tested for catalase and glutathione (GSH) activity.</p><p><strong>Results: </strong>Microspheres loaded with mangiferin reduced the severity of ulcerative colitis caused by acetic acid, as indicated by improvements in weight loss, macroscopic score, ulcer area, and histological score.</p><p><strong>Discussion: </strong>The anti-inflammatory effects of the microspheres may explain their ability to alleviate symptoms of acetic acid-induced ulcerative colitis.</p><p><strong>Conclusion: </strong>These findings suggest that enteric-coated microspheres loaded with mangiferin exhibit a protective effect against colon ulcers in rats and offer delayed-release properties compared to plain mangiferin.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144791197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Navigating Regulatory Complexities in Biosimilar Approvals and Imports for Autoimmune Disorder Management: A Comparative Analysis of FDA (US), EMA (EU), and CDSCO (India) Guidelines. 自身免疫性疾病管理生物仿制药审批和进口的监管复杂性:FDA(美国)、EMA(欧盟)和CDSCO(印度)指南的比较分析
Pub Date : 2025-08-01 DOI: 10.2174/0126673878360952250715031025
John Gerard S, Vasukidevi Ramachandran

Biosimilars offer cost-effective alternatives for autoimmune disorder treatment. However, India's stringent regulatory barriers, including mandatory local trials, unclear interchangeability guidelines, and strict pricing controls, hinder market access. This study conducts a comparative analysis of the FDA (US), EMA (EU), and CDSCO (India) regulatory frameworks, highlighting key differences in approval pathways, post-marketing surveillance, and import regulations. Unlike previous studies, this paper employs a structured SWOT analysis to assess the impact of India's regulatory landscape on biosimilar accessibility. The findings reveal that India's local clinical trial mandates and complex approval processes hinder biosimilar adoption despite prior FDA or EMA approvals. Additionally, the absence of interchangeability guidelines discourages physician confidence, while stringent pricing policies under the Drug Price Control Order (DPCO) reduce manufacturer incentives. To improve biosimilar market penetration, India must streamline regulatory approvals, harmonize clinical trial requirements with international standards, and establish clear interchangeability guidelines. These reforms are essential to enhance the affordability and accessibility of biosimilars in the management of autoimmune disorders.

生物仿制药为自身免疫性疾病的治疗提供了具有成本效益的替代方案。然而,印度严格的监管障碍,包括强制性的地方试验、不明确的互换性指导方针和严格的价格控制,阻碍了市场准入。本研究对FDA(美国)、EMA(欧盟)和CDSCO(印度)的监管框架进行了比较分析,强调了批准途径、上市后监督和进口法规方面的主要差异。与以往的研究不同,本文采用结构化的SWOT分析来评估印度监管格局对生物类似药可及性的影响。研究结果表明,尽管FDA或EMA事先批准了生物仿制药,但印度当地的临床试验授权和复杂的审批程序阻碍了生物仿制药的采用。此外,缺乏可互换性指南打击了医生的信心,而药品价格管制令(DPCO)下严格的定价政策减少了制造商的激励。为了提高生物仿制药市场渗透率,印度必须简化监管审批,使临床试验要求与国际标准相协调,并建立明确的可互换性指导方针。这些改革对于提高自身免疫性疾病管理中生物类似药的可负担性和可及性至关重要。
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引用次数: 0
Aprepitant: Review on Solubility Enhancement. 阿瑞吡坦:提高溶解度的研究进展。
Pub Date : 2025-07-21 DOI: 10.2174/0126673878374342250708153111
Lata Kothapalli, Navdeep Singh, Abhay Upare, Anil Kumar Rathour, Nisha Nikam, Asha Thomas, Sanjeevani S Deshkar

Introduction: Substance P and its neurokinin (NK-1) receptors are upregulated in different pathophysiological conditions. Overexpression of the NK-1 receptor in cancer conditions has provided a promising pathway for cancer treatment. Clinically, Aprepitant (APT) is used as the only NK-1 antagonist in chemotherapy-induced nausea and vomiting (CINV). Currently, investigations into using APT as a synergistic combination with radiation or standard chemotherapeutic drugs are underway. However, APT is categorised as a BCS Class IV drug, and therefore, solubility is one of the challenges when it must be delivered parenterally. The present review aims to understand the solubility enhancement techniques for better bioavailability.

Methodology: Research and review articles were sought to understand the chemistry and solubility enhancement techniques reported for APT. Search engines such as Science Direct, PubMed, Bentham, and Google Scholar were used with the keywords "Aprepitant, solubility, NK1 receptor, parenteral dosage form."

Result: The review comprehensively discusses the methods to improve the solubility of APT using innovative technologies, including nanotechnology.

Discussion: The review highlights the challenges in the utilisation of APT as a treatment for CINV and a promising anticancer drug. Various solubility enhancement techniques can be used for oral administration of APT; however, for parenteral dosage forms, appropriate use of excipients and stability are essential for its safe clinical use.

Conclusion: The available solubility enhancement techniques discussed come with benefits and limitations. Fosaprepitant, a prodrug, is preferably used as an IV dosage form. Similarly, modification to a prodrug and solubility-enhancing excipients for nanoformulation can help make APT a promising therapy.

P物质及其神经激肽(NK-1)受体在不同的病理生理条件下上调。NK-1受体在癌症中的过表达为癌症治疗提供了一条有希望的途径。临床上,阿瑞吡坦(APT)作为唯一的NK-1拮抗剂用于化疗引起的恶心和呕吐(CINV)。目前,将APT与放疗或标准化疗药物协同联合的研究正在进行中。然而,APT被归类为BCS IV类药物,因此,当它必须通过肠外给药时,溶解度是一个挑战。本综述旨在了解提高溶解度的技术,以提高生物利用度。方法:通过研究和综述文章来了解APT的化学和溶解度增强技术。使用Science Direct、PubMed、Bentham和谷歌Scholar等搜索引擎,关键词为“阿瑞匹坦、溶解度、NK1受体、非肠外剂型”。结果:本文全面讨论了利用纳米技术等创新技术提高APT溶解度的方法。讨论:本综述强调了APT作为CINV治疗和一种有前景的抗癌药物所面临的挑战。多种增溶技术可用于口服给药APT;然而,对于肠外剂型,适当使用赋形剂和稳定性对其安全临床使用至关重要。结论:现有的提高溶解度的技术既有优点也有局限性。福沙吡坦是一种前药,优选作为静脉注射剂型使用。同样,对前体药物和纳米制剂的溶解度增强赋形剂进行修饰有助于使APT成为一种有前景的治疗方法。
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引用次数: 0
Formulation, Characterization, and In Vitro Analysis of a Curcumin-Loaded Lecithin-Coconut Oil-Based Emulgel for Enhanced Burn Management. 姜黄素负载卵磷脂-椰子油乳液的配方、表征和体外分析,用于增强烧伤管理。
Pub Date : 2025-07-18 DOI: 10.2174/0126673878362007250707054437
Vishal, Sourav Dhandi, Yeshna, Monika Singh, Monika, Rahul Pratap Singh, Vikas Jhawat

Background: Curcumin has been shown to possess anti-inflammatory and antimicrobial properties, offering potential benefits in burn management. Coconut oil has also been reported to possess skin-moisturizing, antimicrobial, and anti-inflammatory properties. This study aimed to develop and evaluate curcumin-loaded coconut oil-based emulgel formulations to improve therapeutic outcomes in burn management.

Methods: Eight emulgel formulations (F1-F8) were prepared using lecithin, hyaluronic acid, and coconut oil. The formulations were assessed for organoleptic properties (color, smell, texture, phase separation) and physicochemical characteristics, including pH (5.40-6.35), viscosity (3840-5369 cps), spreadability (7-8 cm), drug content (82-95%), and in vitro drug release (88-93%). Light microscopy and scanning electron microscopy (SEM) were used to analyze the structural characteristics. Drug release kinetics were evaluated using the Hixson-Crowell model.

Results: The formulations exhibited a bi-continuous system with a three-dimensional network structure. The developed formulations were evaluated for pH (5.40-6.35), viscosity (3840-5369 cps), spreadability (7-8 cm), drug content (82-95%), and in vitro drug release (88-93%) over 24 hours which showed promising result for topical delivery. Among the formulations, F3 demonstrated the highest drug release, whereas F8 exhibited the highest viscosity and drug content. The emulgel also provided cooling, moisturizing, anti-inflammatory, and antimicrobial effects, supporting wound healing and pain relief.

Conclusion: The developed Curcumin-loaded coconut oil-based emulgel shows promise for burn management, offering enhanced topical drug delivery and therapeutic benefits. These findings support further research to optimize formulation parameters for improved clinical outcomes.

背景:姜黄素已被证明具有抗炎和抗菌特性,在烧伤管理中提供潜在的益处。据报道,椰子油还具有皮肤保湿、抗菌和抗炎的特性。本研究旨在开发和评估含有姜黄素的椰子油乳液配方,以改善烧伤管理的治疗效果。方法:以卵磷脂、透明质酸、椰子油为原料,分别制备f1 ~ f8凝胶配方。评价各制剂的感官特性(颜色、气味、质地、相分离)和理化特性,包括pH值(5.40 ~ 6.35)、粘度(3840 ~ 5369 cps)、涂抹性(7 ~ 8 cm)、药物含量(82 ~ 95%)和体外释药(88 ~ 93%)。利用光镜和扫描电镜对其结构特征进行了分析。采用Hixson-Crowell模型评价药物释放动力学。结果:各配方呈现双连续体系,具有三维网状结构。通过pH值(5.40 ~ 6.35)、黏度(3840 ~ 5369 cps)、涂敷性(7 ~ 8 cm)、药物含量(82 ~ 95%)、24小时体外释药(88 ~ 93%)等指标对所制制剂进行了评价。其中F3的释药量最高,F8的黏度和含药量最高。该乳液还具有冷却、保湿、抗炎和抗菌作用,支持伤口愈合和缓解疼痛。结论:所开发的姜黄素椰子油乳液具有良好的烧伤管理效果,可增强局部药物传递和治疗效果。这些发现支持进一步研究以优化配方参数以改善临床结果。
{"title":"Formulation, Characterization, and In Vitro Analysis of a Curcumin-Loaded Lecithin-Coconut Oil-Based Emulgel for Enhanced Burn Management.","authors":"Vishal, Sourav Dhandi, Yeshna, Monika Singh, Monika, Rahul Pratap Singh, Vikas Jhawat","doi":"10.2174/0126673878362007250707054437","DOIUrl":"https://doi.org/10.2174/0126673878362007250707054437","url":null,"abstract":"<p><strong>Background: </strong>Curcumin has been shown to possess anti-inflammatory and antimicrobial properties, offering potential benefits in burn management. Coconut oil has also been reported to possess skin-moisturizing, antimicrobial, and anti-inflammatory properties. This study aimed to develop and evaluate curcumin-loaded coconut oil-based emulgel formulations to improve therapeutic outcomes in burn management.</p><p><strong>Methods: </strong>Eight emulgel formulations (F1-F8) were prepared using lecithin, hyaluronic acid, and coconut oil. The formulations were assessed for organoleptic properties (color, smell, texture, phase separation) and physicochemical characteristics, including pH (5.40-6.35), viscosity (3840-5369 cps), spreadability (7-8 cm), drug content (82-95%), and in vitro drug release (88-93%). Light microscopy and scanning electron microscopy (SEM) were used to analyze the structural characteristics. Drug release kinetics were evaluated using the Hixson-Crowell model.</p><p><strong>Results: </strong>The formulations exhibited a bi-continuous system with a three-dimensional network structure. The developed formulations were evaluated for pH (5.40-6.35), viscosity (3840-5369 cps), spreadability (7-8 cm), drug content (82-95%), and in vitro drug release (88-93%) over 24 hours which showed promising result for topical delivery. Among the formulations, F3 demonstrated the highest drug release, whereas F8 exhibited the highest viscosity and drug content. The emulgel also provided cooling, moisturizing, anti-inflammatory, and antimicrobial effects, supporting wound healing and pain relief.</p><p><strong>Conclusion: </strong>The developed Curcumin-loaded coconut oil-based emulgel shows promise for burn management, offering enhanced topical drug delivery and therapeutic benefits. These findings support further research to optimize formulation parameters for improved clinical outcomes.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144683971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nanosponges in Detoxification: Strategy for Toxin Removal and Drug Overdose Management. 纳米海绵解毒:毒素去除和药物过量管理策略。
Pub Date : 2025-07-17 DOI: 10.2174/0126673878375572250629214237
Nishtha Sakhuja, Khushi, Chirag Jain, Shikha Baghel Chauhan, Indu Singh

A potential class of cutting-edge medication delivery devices, nanosponges have become an effective tool for managing drug overdoses and detoxification. The capacity to adsorb and sequester a variety of toxins, such as heavy metals, bacterial endotoxins, and medications, makes these highly porous, biocompatible, and biodegradable particles-which are usually made from crosslinked polymers-an effective way to remove toxins. Nanosponges' adaptability enables their use in a number of sectors, including drug-resistant illness treatment, environmental remediation, and acute poisoning treatment. Detoxification and targeted drug release for diseases like cancer, heart disease, and neurological problems are made possible by the controlled delivery of therapeutic substances using nanosponges. With a focus on their capacity to improve medication bioavailability and lower systemic toxicity, this study examines the mechanism of action, design approaches, and therapeutic potential of nanosponges in detoxification. The paper also discusses new developments in the sector, such as how they can be used to treat drug overdoses and how nanosponges can help stop and lessen the negative effects of environmental contaminants. Despite its potential, there are still obstacles to overcome in order to maximize nanosponges' manufacturing, scalability, and regulatory acceptance. In order to optimize their potential in therapeutic treatments, this review attempts to give a thorough overview of the most recent advancements in detoxifying nanosponges, their clinical uses, and future research objectives.

纳米海绵是一种潜在的尖端药物输送设备,已经成为控制药物过量和解毒的有效工具。吸附和隔离各种毒素的能力,如重金属、细菌内毒素和药物,使这些高多孔性、生物相容性和可生物降解的颗粒——通常由交联聚合物制成——成为清除毒素的有效方法。纳米海绵的适应性使其能够应用于许多领域,包括耐药疾病治疗、环境修复和急性中毒治疗。通过使用纳米海绵控制治疗物质的输送,癌症、心脏病和神经系统问题等疾病的解毒和靶向药物释放成为可能。本研究着眼于纳米海绵提高药物生物利用度和降低全身毒性的能力,探讨了纳米海绵在解毒中的作用机制、设计方法和治疗潜力。这篇论文还讨论了该领域的新发展,例如它们如何用于治疗药物过量,以及纳米海绵如何帮助阻止和减轻环境污染物的负面影响。尽管其潜力巨大,但为了最大限度地提高纳米海绵的制造、可扩展性和监管接受度,仍有一些障碍需要克服。为了优化其在治疗治疗中的潜力,本文综述了解毒纳米海绵的最新进展、临床应用和未来的研究目标。
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Recent advances in drug delivery and formulation
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